Kornimate/medical-research-clean huggingface dataset:
lidocaine and dexmedetomidine infusion and their combination on perioperative pain in patients undergoing video-assisted thoracoscopic surgery

Conditions: Lidocaine; Dexmedetomidine; Infusion; Perioperative Pain; Video-Assisted Thoracoscopic Surgery

Summary: this study aims to compare lidocaine and dexmedetomidine infusion and their combination on perioperative pain in patients undergoing video-assisted thoracoscopic surgery.

video-assisted thoracoscopic surgery (vats) is a minimally invasive procedure allowing the reduction of surgical stress. however, postoperative pain management is crucial for patients undergoing vats, as inadequate pain control can lead to complications (such as lung atelectasis), prolonged recovery, and decreased patient satisfaction. dexmedetomidine has shown positive effects on postoperative pain intensity, opioid consumption and other recovery parameters, such as postoperative nausea and vomiting (ponv), and speed of recovery. lidocaine has exhibited an excellent safety profile when administered as a low-dose infusion for cancer or non-cancer chronic pain.

Eligibility criteria:
inclusion criteria: * age ≥18 years old. * both sexes. * american society of anesthesiologists (asa) physical status of i, ii. * patients undergoing video-assisted thoracoscopic surgery (vats) under general anesthesia. exclusion criteria: * hypersensitivity to any of the used drugs. * coagulation disorder. * body mass index \>35 kg/m2. * history of chronic pain requiring daily opioids/steroids/clonidine/other α2 agonist/analgesics or any drugs acting on the central nervous system during the previous 2 weeks, and drug/alcohol abuse. * contraindication to the use of local anesthetics. * cardiovascular disease. * severe respiratory, renal or hepatic impairment. * insulin-dependent diabetes mellitus. * central nervous system or psychiatric disease.
standard dressing versus moist dressing in the course of the postoperative wound in patients with knee prosthesis

Conditions: Surgical Wound; Knee Disease

Summary: the aim of the study is: to evaluate the efficacy of two post-operative dressings in the management of the surgical wounds in patients who received a knee prosthesis

this was a randomised, controlled, clinical trial on patients who received a primary knee prosthesis in 2018-2019. treatment group was given a multi-layer foam dressing with safetac. the control group received standard treatment with povidone-iodine and a gauze dressing with plaster. 50 patients was needed for sufficient power. primary outcome measures were; the characteristics of the surgical wound, patient reported comfort and adaptability according to the physiotherapist. secondary outcome measures were: the clinical status and quality of life level according to the western ontario and mcmaster universities osteoarthritis index (womac). statistical analysis was performed by using ibm spss version 25, with a statistical significance of 5%.

Eligibility criteria:
inclusion criteria: * surgical intervention of total primary knee prosthesis * informed consent approved and signed by participants. exclusion criteria: * sensitivity or allergy to study dressings

Keywords: surgical wound healing knee arthroplasty postoperative dressings
e-chec-up: scaling up an efficacious cancer screening intervention for women with limited english

Conditions: Breast Cancer; Cervical Cancer

Summary: this research is being done to learn more about whether or not korean american women will improve the screening practices for breast and cervical cancer if subjects receive education and follow-up from community health workers. the education materials may be given via online or in-person. primary hypothesis: e-chec-up will be as efficacious as the original chec-up in promoting mammogram and pap test screening among korean immigrant women (kiw) at 6 months. objectives: (1) to develop a web-based platform of the health literacy education component of the original chec-up intervention; (2) to evaluate the acceptability and usability of the web version of the health literacy education in a user testing sample of 10 kiw; and (3) to conduct a pilot study to test the preliminary efficacy of the web version of chec-up (e-chec-up) in 40 kiw.

e-chec-up stands for e-community based breast and cervical cancer control education program.

Eligibility criteria:
inclusion criteria: * age 21-65 years * self-identified as a korean american woman * overdue for a mammogram (40-65 years of age only) or a pap test\*\* * able to read and write korean or english * willing to provide written consent to allow the researchers to audit medical records for mammography and pap test use exclusion criteria: * a cancer diagnosis * being pregnant * an acute and/or terminal condition (e.g., life expectancy of less than 6 months or last cancer treatment within the last 5 years) * psychiatric diagnosis (e.g., schizophrenia or cognitive impairment) or other conditions that preclude participation in the study activities * had undergone a hysterectomy
a study of car-t cells in subjects with autoimmune diseases

Conditions: Autoimmune Diseases

Summary: the purpose of this study is to assess the safety and efficacy of car-t cell therapy in subjects with autoimmune diseases.

this study is a single center, one-arm, open label study aimed at evaluate the safety and efficacy of car-t cells to treating subjects with autoimmune diseases.

Eligibility criteria:
key inclusion criteria: 1. male or female, between 18 and 65 years old; 2. diagnosed with autoimmune diseases, such as systemic lupus erythematosus, systemic sclerosis, idiopahic inflammatory myopathies, anti-neutrophil cytoplasmic antibody-associated vasculitis, sjögren's syndrome, antiphospholipid syndrome, immune thrombocytopenia； 3. good organ functions; 4. voluntary participates this trial and can comprehend and sign icf. key exclusion criteria: 1. had or has active malignancy; 2. had been subjected to treatment by cd19 targeted therapy or car-t therapy or any gene therapy; 3. combined with other autoimmune disease that needs treatment; 4. pregnant or lactating women; 5. has other factors that deemed not suitable by investigator.
multicentre observational study on the wound pain relief properties of ortodermina®

Conditions: Wound Healing Disorder

Summary: acute pain may occur due to trauma, surgery, infection, disruption of blood circulation or when there is tissue injury. it can be managed using analgesics and conduction anaesthesia, which may be preferable because of superior pain control and fewer side effects. lidocaine hydrochloride is used topically to relieve itching, burning and pain from skin inflammation. this multicentric observational study is aimed to evaluate the relief gained with lidocaine hydrochloride (ortodermina®) on wound pain in patients with painful wounds and to collect safety information on this treatment.

acute pain can be managed using analgesics and conduction anaesthesia which may be preferable because of superior pain control and fewer side effects. in this contest, lidocaine hydrochloride (ortodermina®) plays an important role in pain management during wound healing. the properties of ortodermina® and its ability to maintain an adequate level of active drug over the lesion allow a persistent anaesthetic effect. ortodermina® is a drug for topical application in the form of cream, with a high safety profile. however, although the incidence of adverse effects with lidocaine ointment 5% is quite low, caution should be exercised, particularly when employing large amounts, since the incidence of adverse effects is directly proportional to the total dose of local anaesthetic agent administered. this multicentric observational study is aimed to evaluate the relief gained with ortodermina® on wound pain in patients with painful wounds and to collect safety information on this treatment.

Eligibility criteria:
inclusion criteria: * age \>18 years * patients with painful exuding wounds \>1 cm2 that includes painful exuding ulcers and pressure ulcers grade ii \[according to national pressure ulcer advisory panel (npuap) classification\] * patients available and able to return to the study site for the scheduled visits * patients who gave written informed consent to take part into the study exclusion criteria: * patients with ulcer infected, discoloured, odorous, pressure ulcer grade i, iii, or iv (according to npuap classification) * diabetic foot ulcer * patients with contraindication or known allergy to drug's components * patients with known severe allergies manifested by a history of anaphylaxis, or history or presence of severe multiple allergies * patients who are pregnant or lactating. * patients with vascular disorders (mainly arteriopathies) * patients known as alcohol or drug abusers. * patients currently participating in a clinical study

Keywords: wound healing pain lidocaine
a study of fk199b to compare efficacy with zolpidem by polysomnography in patients with insomnia

Conditions: Sleep Initiation and Maintenance Disorders

Summary: this study is to investigate the efficacy and safety of fk199b (zolpidem mr tablet) by polysomnography in patients with insomnia, excluding patients with schizophrenia or manic-depressive psychosis.


Eligibility criteria:
inclusion criteria: * patient is diagnosed as a primary insomnia according to the diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) * patients complaining of insomnia continuously for 4 weeks or longer * patient's usual bedtime is between 9 p.m. and 12 a.m. for the 4 week period prior to initial screening * patient on most occasions sleeps for a total of ≥3 and \<6.5 hours over the 4 week period prior to initial screening * patient's usual wake time after sleep onset in a single night is ≥45 minutes per night for the 4 week period prior to initial screening * patients have a body weight of ≥45 kg and ≤85 kg, a bmi of ≥18.5 and \<30 exclusion criteria: * patients with schizophrenia or manic-depressive psychosis * patients with insomnia caused by physical diseases including chronic obstructive pulmonary disease, bronchial asthma, fibrositis syndrome, chronic fatigue syndrome, rheumatic disease, climacteric disturbance, and dermatitis atopic * patients with circadian rhythm sleep disorder * patient works night shifts * patients with alcoholic sleep disorder * patients with alcohol or drug dependence or a history of these * patients with insomnia related with drugs including antiparkinson, antihypertensive, or steroid drugs * patients with sleep apnea syndrome * patients with restless legs syndrome or periodic limb movement disorder * patients with epileptic insomnia * patients smoke on average 40 or more cigarettes a day * patients who had received psychotropic drugs other than hypnotics (including anxiolytic or antidepressant drugs for hypnotic effect) within a 4 week period prior to the initial screening

Keywords: fk199b zolpidem
impact of dna repair pathway alterations on sensitivity to radium-223 in bone metastatic castration-resistant prostate cancer

Conditions: Castration-Resistant Prostate Carcinoma; Metastatic Malignant Neoplasm in the Bone; Metastatic Prostate Carcinoma; Stage IVB Prostate Cancer AJCC v8

Summary: this study investigates how well radium-223 works in treating patients with castration-resistant prostate cancer than has spread to the bones (bone metastases). prostate cancer is the most common cancer in men and the second leading cause of cancer death. furthermore, many men with notably advanced disease have been found to have abnormalities in dna repair. the purpose of this research is to study the role of a dna repair pathway in prostate cancer, specifically in response to administration of radium-223, an fda-approved drug known to cause dna damage to cancerous cells. understanding how defects in the dna repair pathway affects radium-223 treatment of prostate, may help doctors help plan effective treatment in future patients.

outline: patients receive standard of care radium ra 223 dichloride given by intravenous (iv) bolus every 4 weeks for up to 6 cycles. patients undergo collection of blood every 1-3 months during radium ra 223 dichloride treatment. after completion of study, patients are followed up every 3 months for up to 5 years from the date of treatment completion.

Eligibility criteria:
inclusion criteria: * patient must be \>= 18 years of age * patient must have histopathologic diagnosis of prostate cancer * patient must have castration-resistant prostate cancer * patient must have radiographic evidence of bone metastasis * patients must be symptomatic from prostate cancer * patient must have plans to undergo treatment with radium-223 * patient must have a psa level \>= 10 ng/ml * patient must have castrate testosterone levels demonstrated within the last 3 months prior to screening * patient must have anticipated survival \> 3 months * patient must be willing and able to authorize consent * patient must be willing and able to comply with the protocol, including follow-up visits exclusion criteria: * patient must not have visceral metastasis * patients on regimens of radium-223 in combination with other antineoplastic agents are excluded \* bone-targeted only therapy (e.g. denosumab or zoledronic acid) will be allowed * patients who have received prior radium-223 * patients who have received prior platinum containing chemotherapy * absolute neutrophil count (anc) \< 1.5 x 10\^9/l * hemoglobin (hb) \< 9 g/dl * platelets (plt) \< 100 x 10\^9/l * any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation

Keywords: prostate
iv acetaminophen as an analgesic adjunct

Conditions: Acute Pain

Summary: to determine the efficacy of intravenous (iv) acetaminophen as an analgesic adjunct to iv hydromorphone in the treatment of acute severe pain in the elderly emergency department (ed) patients.

a randomized controlled trial to determine the efficacy of 1 gram iv acetaminophen as an analgesic adjunct to 0.5 mg iv hydromorphone in the treatment of acute severe pain in the elderly ed patients.

Eligibility criteria:
inclusion criteria: * acute (less than 1 week in duration) severe pain necessitating use of intravenous (iv) opioids in the judgement of the treating attending physician exclusion criteria: * use of other opioids or tramadol within past 24 hours: to avoid introducing assembly bias related to recent opioid use, since this may affect baseline levels of pain and need for analgesics. * prior adverse reaction to hydromorphone, morphine, or acetaminophen. * chronic pain syndrome: frequently recurrent or daily pain for at least 3 months results in modulation of pain perception which is thought to be due to down-regulation of pain receptors. examples of chronic pain syndromes include sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies. * alcohol intoxication: the presence of alcohol intoxication as judged by the treating physician may alter pain perception. * systolic blood pressure (sbp) \<100 mm hg: opioids can produce peripheral vasodilation that may result in orthostatic hypotension. * heart rate (hr) \< 60/min: opioids can cause bradycardia. * oxygen saturation \< 95% on room air: for this study, oxygen saturation must be 95% or above on room air in order to be enrolled. * use of monoamine oxidase (mao) inhibitors in past 30 days: mao inhibitors have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant respiratory depression or coma. * patients using transdermal pain patches

Keywords: older adults elderly acute pain iv acetaminophen iv hydromorphone analgesia adjunctive analgesia
conventional and metabolomic predictors of prediabetes & insulin resistance

Conditions: PreDiabetes; Obesity, Childhood

Summary: the purpose of this study is to evaluate the longitudinal test performance of an array of conventional biomarkers of glycemia, including hemoglobin a1c (hba1c), and novel metabolomic biomarkers for identifying progression of glucose tolerance (normal to prediabetes or prediabetes to diabetes) in an overweight and obese pediatric cohort.


Eligibility criteria:
inclusion criteria: * groups 1 and 2 (overweight and obese groups): * age 8-17 years for the visits #1 and #2, individuals can be as old as 22 years for follow-up visits #3 and 4 * overweight or obese, as defined by a bmi ≥ 85th% \& \<95th% or bmi ≥ 95th%, respectively by age and sex, and for those 16 years and older, bmi ≥25 and \<30 and bmi ≥30 * for group 2 only: previously completed visits 1-2 in 2007-2013 and formally agreed to be re-contacted for study purposes * group 3 (normal weight controls): * age 8-17 years * healthy weight, as defined by a bmi ≥ 5th percentile \& \< 85th percentile, respectively by age and sex exclusion criteria: * previous diagnosis of type 1 diabetes * use of concurrent medications known to affect glucose metabolism (metformin, oral steroids, sulfonylureas, insulin) * verbal report of pregnancy
evaluation of standard of care practices, procedural outcomes and in-hospital complications of peripheral endovascular procedures

Conditions: Peripheral Arterial Disease

Summary: significant advances in dedicated materials and techniques along with increased operator experience led to a significant increment in procedural success rate of peripheral endovascular interventions, exceeding 90% in expert hands with reported low procedural complication rates. however, there are still lack of data on procedural outcomes, in-hospital complications, and resource utilization on treatment of (complex) lesions in the femoral, popliteal and infrapopliteal artery in the real-world condition in europe.

the study will enroll consecutive eligible subjects who have peripheral artery disease (pad) requiring endovascular treatment of de-novo and restenotic atherosclerotic lesions in femoral, popliteal and infrapopliteal arteries. the purpose of this prospective, multicenter, observational european study is to evaluate the standard of care practices, procedural outcomes, and in-hospital complications of endovascular peripheral interventions for treatment of lesions in the femoral, popliteal and infrapopliteal arteries.

Eligibility criteria:
inclusion criteria: 1. subject ≥18 years old 2. subject has provided written informed consent 3. subject has rutherford classification 2 to 6 4. reference vessel diameter ≥2 and ≤7 mm 5. target lesion(s) has stenosis \>70% by visual assessment 6. multiple consecutive single lesions with a healthy segment(s) of ≤ 3cm in-between the lesions will be considered one lesion. for above the knee (atk) group 7. target lesions located in the superficial femoral artery or popliteal arteries (above the tibial plateau) 8. at least 1 below-knee artery patent to the ankle 9. successful treatment of inflow iliac stenosis to the target lesion. inflow lesion stenosis can be treated during the same procedure as per local standard of care. for below the knee (btk) group: 10. target lesions involve arteries below the tibial plateau 11. successful treatment of inflow vessel (from ipsilateral iliac to the target lesion) resulting in ≤30% residual stenosis with no evidence of embolization or significant complications. exclusion criteria: 1. subject has a single target lesion that involves both atk and btk segment. 2. subject not suitable for receiving endovascular procedures of lower limb arteries 3. prior planned major amputation in the target limb (above the ankle) 4. subject with previous bypass surgery of target vessel. 5. history of any open surgical procedure within the past 30 days. 6. planned vascular surgery procedure within the next 30 days after the atk and/or btk procedure on the target limb. note: the inflow vessels can be treated on the day of the procedure 7. subject under dialysis 8. subject currently enrolled in another investigational device, biologic, or drug trial in which the primary endpoint has not yet been reached 9. subject lacking capacity to provide informed consent 10. subject under judicial protection, tutorship, or curatorship (for france only)
study to evaluate the effect of sulforaphane in broccoli sprout extract on breast tissue

Conditions: Breast Cancer

Summary: the purpose of this research is to examine the effect of a broccoli sprout preparation on specific factors in breast tissue that are related to breast cancer risk and to assess whether sulforaphane a key component of broccoli sprouts increases the levels of protective enzymes in breast tissue. in addition, the investigators will also examine how acceptable the broccoli sprouts preparation is to the study participants.

a double-blind randomized phase ii chemoprevention trial of bse versus placebo will be conducted in up to 35 women diagnosed with dcis on core biopsy prior to their definitive surgery (study diagram below). the primary study endpoint will be a decrease in the mean proliferative rate measured by ki67%. women diagnosed with dcis on core or incisional/excisional biopsy scheduled for definitive surgery at johns hopkins hospital will be recruited for this study. participants will be placed on a cruciferous free diet for the 14 days prior to their surgical date and drink a randomized intervention beverage (mango juice with or without broccoli sprout extract). additionally participants will provide 2 blood and 2 urine sample collections, report medication use and adverse events using prepared forms and complete a daily diet check list during the 14 day intervention. on the day of definitive breast surgery, 1-2 grams of breast tissue (including normal adjacent breast tissue) will be collected during surgery.

Eligibility criteria:
inclusion criteria: * female 18 + years of age * confirmed diagnosis of dcis on core or excisional/incisional biopsy and scheduled for definitive surgery * pre or post menopausal women reporting no use of hormone replacement therapy, tamoxifen or raloxifene within the prior 6 months to eligibility screening * agree to avoid cruciferous vegetable/condiment intake for 14 days * agree to sign an informed consent and allow use of some tissue (slides) from biopsy and definitive surgery for research purposes exclusion criteria: * prior cancer diagnosis other than non-melanomatous skin cancer or cervical carcinoma in-situ * used hormone replacement therapy, tamoxifen or raloxifene within the past 6 months prior to eligibility screening * used antibiotics within 10 days prior to beginning cruciferous free diet (day -14 prior to surgery) * smoked within the past 12 months prior to eligibility screening; * active infection or inflammation of the breast at time of eligibility screening * has baseline comprehensive metabolic panel (cmp) \[glucose, calcium, albumin, serum total protein (tp), sodium, potassium, carbon dioxide, chloride, blood urea nitrogen (bun), creatinine, alkaline phosphatase (alp), alanine amino transferase (ast), aspartate amino transferase (sgot), and bilirubin\], prothrombin time (pt) and , complete blood count (cbc) values that are 1.5 times in either direction the reported normal range

Keywords: broccoli sprout extract breast cancer
the impact of past coronavirus disease 19 (covid-19) infection on the live birth rates of frozen embryo transfer cycles

Conditions: COVID-19; Frozen Embryo Transfer

Summary: this is a prospective observational study. in this study, we aim to investigate the effect of a recent past covid-19 infection on the live birth rate in the frozen embryo transfer cycles


Eligibility criteria:
inclusion criteria: 1. women aged 20-42 years at the time of ovarian stimulation for in vitro fertilization 2. women have embryos frozen prior to covid infection. exclusion criteria: 1. previous covid infection before oocyte retrieval 2. recipient of oocyte donation 3. undergoing preimplantation genetic testing 4. presence of hydrosalpinx or endometrial polyp which is not surgically treated